Comparing PARACETAMOL or TRAMADOL in the treatment of pain due to renal stones in the emergency department.
- Conditions
- Health Condition 1: null- Patients coming to emergency department with acute colicky pain either due to renal or ureteric calculi.
- Registration Number
- CTRI/2018/09/015698
- Lead Sponsor
- Department of Emergency Medicine Sri Ramachandra University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients between 18 to 60 years of age.
2. Patients presenting with unilateral colicky acute flank pain diagnosed as acute renal colic based on their chief complaint, history, physical examination, past medical history, urinalysis, ultrasonography and CT Scan findings consistent with the diagnosis of renal colic.
3. Patients with a visual analog scale (VAS) pain score of >=40/100.
1. Patient with an allergy to aspirin, paracetamol, tramadol or any opioid analgesic.
2. Patient with hemodynamic instability.
3. Patient with a fever greater than 38â??C (100.40F).
4. Patient with evidence of peritoneal inflammation.
5. Pregnant patients or those suspected to be pregnant or breastfeeding.
6. Patient with proven or suspected aortic aneurysm or dissection.
7. A patient who have used any analgesic drug up to 6 hours before evaluation.
8. Patients with a history of peptic ulcer disease, asthma, bleeding disorder (including the use of oral anticoagulant).
9. Patient with history of heart failure, renal failure, respiratory failure, liver failure, kidney transplant patients, and opioid addiction.Â
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the analgesic efficacy of intravenous, single-dose Paracetamol versus Tramadol, which is a change in visual analog scale (VAS) pain score at 20, 30 and 45 minutes after drug administration.Timepoint: VAS pain score at 20, 30 and 45 minutes after drug administration
- Secondary Outcome Measures
Name Time Method The secondary outcome is the need for the use of rescue analgesia at 30 and 45 minutes and the presence of at least one adverse event.Timepoint: Need for rescue analgesia at 30 and 45 minutes.